November 13, 2008

Haptoglobin Genotype Testing Plays Key Role in Diabetes Therapy, Says Synvista

Synvista Therapeutics, a biopharmaceutical company, has announced new data demonstrating that discontinuation of vitamin E in patients with the Hp2-2 diabetes may result in an increased risk of heart attack and rapid deterioration of HDL function.

In a prospective study called Icare, 2,241 individuals with diabetes mellitus age 55 or over from 47 primary-care clinics in Israel underwent haptoglobin (Hp) genotype testing and were randomized to receive either vitamin E or placebo.

The subjects were then followed for three years to track heart attack, stroke and death. During the study, it was determined that those who had the Hp2-2 genotype and who also received vitamin E had a significantly lower incidence of myocardial infarction (MI) compared to placebo. Also, high-density lipoprotein (HDL) function was significantly improved in Hp2-2 individuals who took vitamin E, compared to placebo.

Following the study, it was discovered that in those Hp2-2 individuals who had received vitamin E, the incidence of MI after stopping vitamin E treatment significantly increased (0.4% on vitamin E versus 1.8% off vitamin E, p=0.03). However, only two months after vitamin E withdrawal, HDL function had deteriorated to its level of dysfunction prior to the initiation of the study.

Furthermore, in the 15-month period following the termination of the study, there was little demonstrable difference in the incidence of MI in those Hp2-2 individuals who had received vitamin E and stopped taking it after the end of the study compared to those who received placebo (1.8% vitamin E versus 1.7% placebo, p=0.9).

Noah Berkowitz, president and CEO of Synvista Therapeutics, said: "These types of studies provide confirmation that our clinical laboratory test which determines haptoglobin genotype may be useful in selecting and guiding patient therapy. We believe that the use of our test will be an important facilitator of personalized medicine and will provide a standard by which physicians can influence clinical outcome."